As an integral member of our Quality Unit, you will be accountable for change control assessment, compliance of manufacturing activities vs regulatory filing, provision of regulatory documents and regulatory intelligence and local expertise in RA. Your role : Review and assess changes reportability to health authorities and approve minor changesReview and approve any relevant GMP documentation against applicable regulatory filings and marketing authorizationsCoordinate collation of regulatory deliverables (data/documents) to support regulatory submissions and assist in the Answers to Objections of Health AuthoritiesResponsible for some technical regulatory writing (in CTD format)Coordinate local review of regulatory CMC modules of the registration fileBring the attention of the Site QA any new compendial or revised monographs concerning regulatory procedures or any compendia product monograph, new Health Authority guidelines or inquiry (regulation compliance) and provide support for appropriate and timely implementation to ensure compliance Who you are:Biologist, pharmacist or other Life Science-related discipline, you have a relevant experience in biotechnological manufacturingTraining or education in regulatory, you have experience in interaction with regulatory agenciesFluently spoken and written English and French. A third European language would be an advantage.Good editorial and communication skillsOrganisation, structure and coordination have no secret for you You are known for your ability to be purposeful, result-driven and collaborative.